The development of patient-centric sampling as an enabling technology for clinical trials

Bioanalysis ◽  
2020 ◽  
Vol 12 (13) ◽  
pp. 971-976 ◽  
Author(s):  
Kevin P Bateman
Keyword(s):  
Clinical Trials ◽  
Human Biology ◽  
Information Revolution ◽  
Enabling Technology ◽  
Short Term ◽  
Blood Samples ◽  
Global Pandemic ◽  
Potential Benefits ◽  
Patient Centric ◽  
At Home

Accessing patient samples using a whenever/wherever paradigm is needed to enable a better understanding of human biology and disease. The technology for convenient self-collection of blood samples by patients at home is quickly becoming available. The potential benefits of patient-centric sampling far outweigh the short-term challenges associated with implementation of this disruptive approach. This is especially true given we are amid a global pandemic and enabling patients to sample at home would help not only clinical trials, but healthcare in general. This perspective article aims to convince the reader that patient-centric sampling is a reality and that we are on the cusp of an information revolution in clinical trials that will be enabled by patient-centric (e.g., at home) sampling.

Cellular Uptake and Magneto-Hyperthermia Induced Cytotoxicity using Photoluminescent Fe3O4 Nanoparticle/Si Quantum Dot Hybrids

2020 ◽  
Author(s):  
Morteza Javadi ◽  
Van A. Ortega ◽  
Alyxandra Thiessen ◽  
Maryam Aghajamali ◽  
Muhammad Amirul Islam ◽  
...  
Keyword(s):  
Radio Frequency ◽  
Biomedical Applications ◽  
Short Term ◽  
Water Dispersible ◽  
Optical Responses ◽  
Si Quantum Dot ◽  
Real World Applications ◽  
Potential Benefits ◽  
Low Toxicity ◽  
Si Quantum Dots

<p>The design and fabrication of Si-based multi-functional nanomaterials for biological and biomedical applications is an active area of research. The potential benefits of using Si-based nanomaterials are not only due to their size/surface-dependent optical responses but also the high biocompatibility and low-toxicity of silicon itself. Combining these characteristics with the magnetic properties of Fe<sub>3</sub>O<sub>4</sub> nanoparticles (NPs) multiplies the options available for real-world applications. In the current study, biocompatible magnetofluorescent nano-hybrids have been prepared by covalent linking of Si quantum dots to water-dispersible Fe<sub>3</sub>O<sub>4</sub> NPs <i>via</i> dicyclohexylcarbodiimide (DCC) coupling. We explore some of the properties of these magnetofluorescent nano-hybrids as well as evaluate uptake, the potential for cellular toxicity, and the induction of acute cellular oxidative stress in a mast cells-like cell line (RBL-2H3) by heat induction through short-term radio frequency modulation (10 min @ 156 kHz, 500 A). We found that the NPs were internalized readily by the cells and also penetrated the nuclear membrane. Radio frequency activated nano-hybrids also had significantly increased cell death where > 50% of the RBL-2H3 cells were found to be in an apoptotic or necrotic state, and that this was attributable to increased triggering of oxidative cell stress mechanisms. </p>

Introduction

2017 ◽  
Author(s):  
Frances Harris
Keyword(s):  
Cultural Influences ◽  
Short Term ◽  
Historical Figures ◽  
Platonic Love ◽  
Close Friendship ◽  
The Ideal ◽  
At Home

This introduces the Marlborough-Godolphin partnership as not just a political alliance, but a close friendship founded on ideals of platonic love and heroic virtue. It reviews the various discourses of friendship, noting the cultural influences (the essayists Montaigne, Sir William Temple, Saint-Évremond, as well as heroic drama and opera) which carried the ideal forward, but with the growing sense that it must prove itself in actual human transactions. It suggests that studying the Marlborough-Godolphin friendship as it proved itself in war abroad and party conflict at home is revealing of two historical figures whom historians have often found enigmatic, though in the end their commitment to it contributed to their short-term failure as well as their longer-term success. The distinction between friendship and royal favour is also touched on.

scholarly journals Staying Home, Staying Alive: Campus Food Pantry Student Clients’ Experiences During the COVID-19 Pandemic

2021 ◽  
pp. 193672442110356
Author(s):  
Elmira Jangjou
Keyword(s):  
Coping Strategies ◽  
Thematic Analysis ◽  
Future Research ◽  
Postsecondary Students ◽  
Structured Interviews ◽  
Short Term ◽  
Income Loss ◽  
Food Pantry ◽  
Global Pandemic ◽  
Seeking Help

In response to students’ food insecurity, a number of colleges and universities have taken action and established campus food pantries as part of their intervention plans. However, many of these pantries ceased operation due to COVID-19 campus shutdowns. The purpose of this study is to illustrate the short-term impacts of the COVID-19 pandemic on postsecondary students, who use a university-provided food pantry. Drawing from semi-structured interviews with 12 participants, the thematic analysis explored the initial coping strategies these students used to endure the pandemic. Findings revealed that many students experienced the immediate effects of the pandemic in the form of income loss, self-isolation, anxiety, and appetite change. Although the pandemic interrupted these students’ journeys to continue their studies and become independent in various ways, the affected students implemented various coping strategies, including seeking help from family or friends, using available resources, cooking at home, and even trying to save money. However, considering that the targeted population in this study was already at risk because of their basic needs insecurity, these postsecondary students require extra attention from their higher education institutions in the case of emergencies, such as a global pandemic. In addition to its timely and relevant findings, this study provides important avenues for future research and intervention efforts.

scholarly journals Spontaneous improvement of carbohydrate-deficient transferrin in PMM2-CDG without mannose observed in CDG natural history study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Peter Witters ◽  
Andrew C. Edmondson ◽  
Christina Lam ◽  
Christin Johnsen ◽  
Marc C. Patterson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural History ◽  
Randomized Study ◽  
Short Term ◽  
Double Blind ◽  
Natural History Study ◽  
Natural History Studies ◽  
Carbohydrate Deficient Transferrin ◽  
Spontaneous Improvement

AbstractA recent report on long-term dietary mannose supplementation in phosphomannomutase 2 deficiency (PMM2-CDG) claimed improved glycosylation and called for double-blind randomized study of the dietary supplement in PMM2-CDG patients. A lack of efficacy of short-term mannose supplementation in multiple prior reports challenge this study’s conclusions. Additionally, some CDG types have previously been reported to demonstrate spontaneous improvement in glycosylated biomarkers, including transferrin. We have likewise observed improvements in transferrin glycosylation without mannose supplementation. This observation questions the reliability of transferrin as a therapeutic outcome measure in clinical trials for PMM2-CDG. We are concerned that renewed focus on mannose therapy in PMM2-CDG will detract from clinical trials of more promising therapies. Approaches to increase efficiency of clinical trials and ultimately improve patients’ lives requires prospective natural history studies and identification of reliable biomarkers linked to clinical outcomes in CDG. Collaborations with patients and families are essential to identifying meaningful study outcomes.

scholarly journals Mechatronic Design of a Robot for Upper Limb Rehabilitation at Home

2021 ◽  
Vol 18 (4) ◽  
pp. 857-871
Author(s):  
Elio Matteo Curcio ◽  
Giuseppe Carbone
Keyword(s):  
Design Process ◽  
Upper Limb ◽  
Experimental Tests ◽  
Design Solution ◽  
Upper Limb Rehabilitation ◽  
Potential Benefits ◽  
Significant Cost Reduction ◽  
Dynamics Models ◽  
Limb Rehabilitation ◽  
At Home

AbstractThis paper addresses the design of a novel bionic robotic device for upper limb rehabilitation tasks at home. The main goal of the design process has been to obtain a rehabilitation device, which can be easily portable and can be managed remotely by a professional therapist. This allows to treat people also in regions that are not easily reachable with a significant cost reduction. Other potential benefits can be envisaged, for instance, in the possibility to keep social distancing while allowing rehabilitation treatments even during a pandemic spread. Specific attention has been devoted to design the main mechatronic components by developing specific kinematics and dynamics models. The design process includes the implementation of a specific control hardware and software. Preliminary experimental tests are reported to show the effectiveness and feasibility of the proposed design solution.

scholarly journals Analytical validation of a real-time hydrolysis probe PCR assay for quantifying Plasmodium falciparum parasites in experimentally infected human adults

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Claire Y. T. Wang ◽  
Emma L. Ballard ◽  
Zuleima Pava ◽  
Louise Marquart ◽  
Jane Gaydon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Plasmodium Falciparum ◽  
18S Rrna ◽  
Drug Efficacy ◽  
18S Rrna Gene ◽  
Molecular Techniques ◽  
Qpcr Assay ◽  
Rrna Gene ◽  
Analytical Sensitivity ◽  
Blood Samples

Abstract Background Volunteer infection studies have become a standard model for evaluating drug efficacy against Plasmodium infections. Molecular techniques such as qPCR are used in these studies due to their ability to provide robust and accurate estimates of parasitaemia at increased sensitivity compared to microscopy. The validity and reliability of assays need to be ensured when used to evaluate the efficacy of candidate drugs in clinical trials. Methods A previously described 18S rRNA gene qPCR assay for quantifying Plasmodium falciparum in blood samples was evaluated. Assay performance characteristics including analytical sensitivity, reportable range, precision, accuracy and specificity were assessed using experimental data and data compiled from phase 1 volunteer infection studies conducted between 2013 and 2019. Guidelines for validation of laboratory-developed molecular assays were followed. Results The reportable range was 1.50 to 6.50 log10 parasites/mL with a limit of detection of 2.045 log10 parasites/mL of whole blood based on a parasite diluted standard series over this range. The assay was highly reproducible with minimal intra-assay (SD = 0.456 quantification cycle (Cq) units [0.137 log10 parasites/mL] over 21 replicates) and inter-assay (SD = 0.604 Cq units [0.182 log10 parasites/mL] over 786 qPCR runs) variability. Through an external quality assurance program, the QIMR assay was shown to generate accurate results (quantitative bias + 0.019 log10 parasites/mL against nominal values). Specificity was 100% after assessing 164 parasite-free human blood samples. Conclusions The 18S rRNA gene qPCR assay is specific and highly reproducible and can provide reliable and accurate parasite quantification. The assay is considered fit for use in evaluating drug efficacy in malaria clinical trials.

scholarly journals Mining of high throughput screening database reveals AP-1 and autophagy pathways as potential targets for COVID-19 therapeutics

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hu Zhu ◽  
Catherine Z. Chen ◽  
Srilatha Sakamuru ◽  
Jinghua Zhao ◽  
Deborah K. Ngan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Throughput Screening ◽  
Animal Studies ◽  
Cytopathic Effect ◽  
Mechanisms Of Action ◽  
Activity Profile ◽  
Pathway Activity ◽  
Global Pandemic ◽  
Approved Drugs

AbstractThe recent global pandemic of the Coronavirus disease 2019 (COVID-19) caused by the new coronavirus SARS-CoV-2 presents an urgent need for the development of new therapeutic candidates. Many efforts have been devoted to screening existing drug libraries with the hope to repurpose approved drugs as potential treatments for COVID-19. However, the antiviral mechanisms of action of the drugs found active in these phenotypic screens remain largely unknown. In an effort to deconvolute the viral targets in pursuit of more effective anti-COVID-19 drug development, we mined our in-house database of approved drug screens against 994 assays and compared their activity profiles with the drug activity profile in a cytopathic effect (CPE) assay of SARS-CoV-2. We found that the autophagy and AP-1 signaling pathway activity profiles are significantly correlated with the anti-SARS-CoV-2 activity profile. In addition, a class of neurology/psychiatry drugs was found to be significantly enriched with anti-SARS-CoV-2 activity. Taken together, these results provide new insights into SARS-CoV-2 infection and potential targets for COVID-19 therapeutics, which can be further validated by in vivo animal studies and human clinical trials.

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